The objective of this study will be to evaluate the invivo safety and efficacy of a hair care formulation in terms of reduction in grey hair on healthy human subject
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Reduction in grey hair
研究概览
简要总结
OBJECTIVE: The objective of this study will be to evaluate the in-vivo safety and efficacy of a hair care formulation in terms of reduction in grey hair on healthy human subjects
The evaluation will be performed using:Subject’s self assessment questionnaire, Dermatological evaluation: Cosmetic Acceptability, Dermatological evaluation: Efficacy, Phototrichogram Analysis
The study lasts 84 days following the first application of the product.
POPULATION: 36 (18 female & 18 male) subjects will be selected for the study.
The subjects selected for this study are healthy males & females, aged between 20 and 45 years old, segmented into three age groups (Group 1: 20-29 years, Group 2: 30-37 years & Group 3: 38-45 years), having mild to moderate (on scale of 0- 10) greying severity score.
STUDY DURATION: 84 days following the first application of the product.
STUDY DESIGN: Single blind study. Non-Comparative study. Subjects will serve as their own references
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Indian / Asian male & female subjects.
- •Healthy subjects 3) Skin is healthy on the studied anatomic unit 4) Subjects with non-congenital factors contributing to premature graying, such as stress, dietary habits, or environmental exposure & those with congenital factors may also be included, 5) Having a mild to moderate greying severity score in a one-to-one ratio.
排除标准
- •For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •Having refused to give his/her assent by not signing the consent form
- •Taking part in another study liable to interfere with this study
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area
- •Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
- •Having a progressive asthma (either under treatment or last fit in the last 2 years)
- •Being epileptic
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •Having cutaneous hypersensitivity
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products
- •Following a chronic or intermittent medicinal treatment comprising any of the following products:aspirin-based products, anti-inflammatories, antihistamines, anti-coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 12.
结局指标
主要结局
Reduction in grey hair
时间窗: Baseline, Day 28, Day 56 and Day 84
次要结局
未报告次要终点
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.